VARENICLINE

Product NDC: 72162-2219
11-digit product format: 721622219
Labeler code: 72162
Product ID: 72162-2219_a2386f55-4425-4caf-9b74-af9f5a80c2f9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: VARENICLINE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA201962
Marketing category: ANDA
Marketing start: 2023-01-30
Substance: VARENICLINE TARTRATE
Active strength: 1 mg/1
Pharmacologic classes: Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A201962-001	VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB		2023-01-25
A201962-002	VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB		2023-01-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A201962-001	AB
A201962-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201962-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201962-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201962-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201962-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201962-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201962-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201962-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201962-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201962-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201962-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201962-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201962-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201962-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201962-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201962-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-01-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201962-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201962-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-01-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201962-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201962-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-01-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201962-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201962-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-01-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201962-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201962-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-01-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201962-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201962-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-01-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201962-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201962-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-01-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201962-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-01-25	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201962-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-01-25	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201962-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-01-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201962-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-01-25	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A201962-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-01-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201962-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-01-25	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A201962-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-01-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201962-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-01-25	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201962-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-01-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201962-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-01-25	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201962-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-01-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201962-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-01-25	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201962-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-01-25	`a67488948f0b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201962-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201962-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201962-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201962-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201962-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201962-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201962-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201962-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201962-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201962-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201962-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201962-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201962-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201962-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201962-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201962-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201962-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201962-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201962-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201962-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201962-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201962-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201962-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201962-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201962-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201962-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201962-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201962-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201962-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201962-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201962-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A201962-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201962-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A201962-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201962-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201962-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201962-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201962-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201962-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201962-002	AB	1	`a67488948f0b…`

Additional Listing Data#

Finished product: Yes
Brand name base: VARENICLINE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VARENICLINE TARTRATE	1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
82269ASB48	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
636676	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
dc0d2c60-b197-4bbf-a3fd-78e0f5a21440	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f0bb1b01-df09-3a97-b952-a960743e615c	Product name	8	20260223
317a11f5-b985-4a71-b48a-5c9c00753d1c	Product name	1	20220511

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72162-2219-2	VARENICLINE	56 in 1 BOTTLE	TABLET, FILM COATED	56		102
72162-2219-3	VARENICLINE	30 in 1 BOTTLE	TABLET, FILM COATED	30		102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72162-2219-2	EA - Each	72162-2219	8bb711e8-80c9-4656-b697-f84237cc6cc6	1	2024-02-14
72162-2219-3	EA - Each	72162-2219	c1b04b8b-4453-4224-92c5-6030407bef6c	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72162-2219	VARENICLINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	102	Current NDC, 2 package rows	20240718_dc0d2c60-b197-4bbf-a3fd-78e0f5a21440.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VARENICLINE	VARENICLINE	Golden State Medical Supply, Inc.	fa5a2672-2378-c27f-e053-6294a90aba65	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201962 application number: ANDA201962
VARENICLINE	VARENICLINE	Apotex Corp	78d1857f-8708-5410-792f-4a3e5e7971a5	2025-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201962 application number: ANDA201962
VARENICLINE	VARENICLINE	Bryant Ranch Prepack	dc0d2c60-b197-4bbf-a3fd-78e0f5a21440	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201962 application number: ANDA201962 ndc (product): 72162-2219
VARENICLINE	VARENICLINE	Bryant Ranch Prepack	e3cc710d-23d8-4d68-b854-b6f5f4e737fc	2024-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201962 application number: ANDA201962
VARENICLINE	VARENICLINE	A-S Medication Solutions	99414eca-c601-431c-8e84-2066b2e8221c	2023-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201962 application number: ANDA201962
VARENICLINE	VARENICLINE	A-S Medication Solutions	92bc4c24-6c4f-4acf-b747-e3ef0cab1297	2023-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201962 application number: ANDA201962

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
82269ASB48	VARENICLINE TARTRATE	375815-87-5	VARENICLINE TARTRATE
W6HS99O8ZO	VARENICLINE	249296-44-4	VARENICLINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
636676	varenicline 1 MG Oral Tablet	PSN	dc0d2c60-b197-4bbf-a3fd-78e0f5a21440	102
636676	varenicline 1 MG Oral Tablet	SCD	dc0d2c60-b197-4bbf-a3fd-78e0f5a21440	102
636676	varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral Tablet	SY	dc0d2c60-b197-4bbf-a3fd-78e0f5a21440	102

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72162-2219-2	72162221902	56 TABLET, FILM COATED in 1 BOTTLE (72162-2219-2)	2024-01-05	No	No	Current
72162-2219-3	72162221903	30 TABLET, FILM COATED in 1 BOTTLE (72162-2219-3)	2024-01-05	No	No	Current